MEDICATION GUIDE

OXCARBAZEPINE

Oral Suspension USP

Read this Medication Guide before you start taking oxcarbazepine and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about oxcarbazepine?

Do not stop taking oxcarbazepine without first talking to your healthcare provider.

Stopping oxcarbazepine suddenly can cause serious problems.

Oxcarbazepine can cause serious side effects, including:

1. Oxcarbazepine may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include:

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nausea

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tiredness, lack of energy

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headache

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confusion

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more frequent or more severe seizures.

Similar symptoms that are not related to low sodium may occur from taking oxcarbazepine. You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away.

Some other medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.

2. Oxcarbazepine may also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.

Call your healthcare provider right away if you have any of the following:

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swelling of your face, eyes, lips, or tongue

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trouble swallowing or breathing

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a skin rash

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hives

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fever, swollen glands, or sore throat that do not go away or come and go

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painful sores in the mouth or around your eyes

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yellowing of your skin or eyes

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unusual bruising or bleeding

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severe fatigue or weakness

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severe muscle pain

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frequent infections or infections that do not go away

Many people who are allergic to carbamazepine are also allergic to oxcarbazepine . Tell your healthcare provider if you are allergic to carbamazepine.

3. Like otherantiepileptic drugs, oxcarbazepine may cause suicidal thoughts or actions in a verysmall number of people, about 1 in 500.

Call a doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you:

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking oxcarbazepine without first talking to a healthcare provider.

Stopping oxcarbazepine suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is Oxcarbazepine?

Oxcarbazepine is a prescription medicine used:

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alone or with other medicines to treat partial seizures in adults.

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alone to treat partial seizures in children 4 years and older

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with other medicines to treat partial seizures in children 2 years and older.

Who should not take oxcarbazepine?

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Do not take oxcarbazepine if you are allergic to oxcarbazepine or any of the other ingredients in oxcarbazepine . See the end of this leaflet for a complete list of ingredients in oxcarbazepine .

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Many people who are allergic to carbamazepine are also allergic to oxcarbazepine or any of the other ingredients in oxcarbazepine. See the end of this leaflet for a complete list of ingredients in oxcarbazepine.

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Many people who are allergic to carbamazepine are also allergic to oxcarbazepine. Tell your healthcare provider if you are allergic to carbamazepine.

What shouldI tell my healthcare provider before taking oxcarbazepine?

Before taking oxcarbazepine, tell your healthcare provider about all your medical conditions, including if you:

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have or have had suicidal thoughts or actions, depression or mood problems

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have liver problems

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have kidney problems

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are allergic to carbamazepine. Many people who are allergic to carbamazepine are also allergic to oxcarbazepine .

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use birth control medicine. Oxcarbazepine may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use.

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If you become pregnant while taking oxcarbazepine, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

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are breastfeeding or plan to breastfeed. Oxcarbazepine passes into breast milk. You and your healthcare provider should discuss whether you should take oxcarbazepine or breastfeed; you should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking oxcarbazepine with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take oxcarbazepine?

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Do not stop taking oxcarbazepine without talking to your healthcare provider. Stopping oxcarbazepine suddenly can cause serious problems, including seizures that will not stop (status epilepticus).

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Take oxcarbazepine exactly as prescribed. Your healthcare provider may change your dose. Your healthcare provider will tell you how much oxcarbazepine to take.

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Take oxcarbazepine 2 times a day.

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Take oxcarbazepine with or without food.

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Before taking oxcarbazepine oral suspension shake the bottle well and use the oral dosing syringe to measure the amount of medicine needed. Oxcarbazepine oral suspension can be mixed in a small glass of water, or swallowed directly from the syringe. Clean the syringe with warm water and let it dry after each use.

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If you take too much oxcarbazepine , call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking oxcarbazepine?

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Do not drive, operate heavy machinery, or do other dangerous activities until you know how oxcarbazepine affects you. Oxcarbazepine may slow your thinking and motor skills.

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Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking oxcarbazepine until you talk to your healthcare provider. Oxcarbazepine taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

What are the possible side effects of oxcarbazepine?

See “What is the most important information I should know about oxcarbazepine?”

Oxcarbazepine may cause other serious side effects including:

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your seizures can happen more often or become worse

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trouble concentrating

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problems with your speech and language

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feeling confused

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feeling sleepy and tired

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trouble walking and with coordination

Get medical help right away if you have any of the symptoms listed above or listed in “What is the most important information I should know about oxcarbazepine?”

The most common side effects of oxcarbazepine include:

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dizziness

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sleepiness

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double vision

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tiredness

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nausea

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vomiting

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problems with vision

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stomach pain

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trembling

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upset stomach

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problems with walking and coordination (unsteadiness)

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rash

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infections (especially in children)

These are not all the possible side effects of oxcarbazepine. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store oxcarbazepine?

Store oxcarbazepine at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep oxcarbazepine in the original container. Use within 7 weeks of first opening the bottle. Shake well before using.

Keep oxcarbazepine and all medicines out of the reach of children.

General Information about the safe and effective use of oxcarbazepine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use oxcarbazepine for a condition for which it was not prescribed. Do not give oxcarbazepine to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about oxcarbazepine. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about oxcarbazepine that is written for health professionals.

Read these instructions carefully to learn how to use the medicine dispensing system correctly.

The Medicine Dispensing System

There are 3 parts to the dispensing system:

1.

A plastic adapter that you push into the neck of the bottle the first time that you open the bottle. The adapter must always stay in the bottle.

2.

A bottle containing 250 mL of the medicine, with a child resistant cap. Always replace the cap after use.

3.

A 10 mL oral dosing syringe that fits into the plastic adapter to withdraw the prescribed dose of medicine from the bottle.

Preparing the Bottle

1.

Shake the bottle of medicine for at least 10 seconds.

2.

Remove the child resistant cap by pushing it firmly down and turning it counterclockwise - to the left (as shown on the top of the cap).

Note: Save the cap so you can close the bottle after each use.

3.

Hold the open bottle upright on a table and push the plastic adapter firmly into the neck of the bottle as far as you can.

4.

Replace the cap to be sure that the adapter has been fully forced into the neck of the bottle.

Note: You may not be able to push the adapter fully down, but it will be forced into the bottle when you screw the cap back on. Now the bottle is ready to use with the syringe. The adapter must always stay in the bottle. The child resistant cap should seal the bottle in between use.

Taking the Medicine

1.

Shake the bottle well. Prepare the dose right away.

2.

Push and turn the child resistant cap to open the bottle.

Note: Always replace the cap after use.

3.

Check that the plunger is all the way down inside the barrel of the syringe.

4.

Keep the bottle upright and push the syringe firmly into the plastic adapter.

5.

Hold the syringe in place and carefully turn the bottle upside down.

6.

Slowly pull the plunger out so that the syringe fills with some medicine. Push the plunger back in just far enough to completely push out any large air bubbles that may be trapped in the syringe.

7.

Slowly pull the plunger out until the top edge of the black ring dose is exactly level with the marker on the syringe barrel for the prescribed dose.

Note: If the prescribed dose is more than 10 mL, you will need to refill the syringe to make up the full dose.

8.

Carefully turn the bottle upright. Take out the syringe by gently twisting it out of the plastic adapter. The plastic adapter should stay in the bottle.

9.

You can mix the dose of medicine in a small glass of water before it is swallowed, or you can drink it directly from the syringe.

1.

If you mix the medicine with water, add some water to a glass. Push in the plunger on the syringe all the way to empty all the medicine into the glass. Stir the medicine in the water and drink it all.

2.

If you use the syringe to take the medicine, the patient must sit upright. Push the plunger slowly to let the patient swallow the medicine.

10.

Replace the child resistant cap after use.

Cleaning: After use, rinse the syringe with warm water and allow it to dry thoroughly.